ASCO 2019 — Enzalutamide tops other antiandrogens for survival in mHSPC


  • Debra Gordon
  • Oncology Conference reports
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Takeaway

  • 80% of men with metastatic hormone-sensitive prostate cancer (mHSPC) who received the nonsteroidal antiandrogen (NSAA) enzalutamide plus testosterone suppression (TS) were alive after 3 years compared with 72% of men who received other NSAAs plus TS.

Why this matters

  • This is the first mHSPC trial to report OS data of enzalutamide plus TS, as well as outcomes in patients who also received concurrent docetaxel.

Study design

  • ENZAMET trial of 1125 men with mHSPC randomly assigned 1:1 to receive TS plus either enzalutamide or 1 of 3 other antiandrogens: bicalutamide, nilutamide, or flutamide.
  • 503 received early doses of docetaxel.
  • Funder: Astellas Pharma

Key findings

  • At the 3-year interim analysis, patients in the enzalutamide group demonstrated:
    • 33% decrease in the risk for death vs other NSAAs (HR, 0.67; P=.002)
    • 61% reduction in the composite endpoint of time to PSA rise, clinical progression, or death (HR, 0.39; P.001) vs other NSAAs.
    • 60% reduction in time to clinical progression (HR, 0.40; P<.001 vs other nsaas.>
  • Adding docetaxel significantly improved PFS (HR, 0.48; 95% CI, 0.37-0.62), but demonstrated no significant OS benefit.
  • Serious adverse events occurred in 42% of patients receiving enzalutamide vs 34% of those receiving other NSAAs.

Limitations

  • Study not yet complete.

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